Merck & Kelun-Biotech Sac-TMT: Positive Phase 3 Results Boost TNBC Outlook Merck & Kelun-Biotech announced positive Phase 3 results. Sac-TMT met its primary endpoint. The study targeted first-line advanced TNBC. Progression-Free Survival (PFS) was achieved. Merck & Kelun-Biotech's antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT), reported positive outcomes from three Phase 3 trials. The OptiTROP-Breast03 study, evaluating sac-TMT for first-line advanced triple-negative breast cancer (TNBC), successfully met its primary endpoint of Progression-Free Survival (PFS). This significant achievement underscores the drug's potential in a challenging oncology setting, validating its efficacy. These positive results strongly position sac-TMT for regulatory submission. Under FDA guidelines, successful Phase 3 data typically supports a New Drug Application (NDA). The EMA will also consider these findings for a Marketing Authorization Application (MAA). Merck and Kelun-Biotech will now compile comprehensive data packages for review, initiating pre-submission meetings with regulatory bodies. This process aligns with 21 CFR Part 314 for NDA submissions. This success strengthens Merck and Kelun-Biotech's position in the competitive ADC market. It validates their partnership and the broader ADC class. Competitors like Gilead's Trodelvy (sacituzumab govitecan) in TNBC will face increased pressure. This positive data could accelerate sac-TMT's market entry, potentially by late 2027, offering a new treatment option for TNBC patients.